Alert: Send protests letters to the PM of India on Patent Amendment

[Guest guest]

Dear All

As you all know that Affordable Medicines and Treatment Campaign (AMTC) is

monitoring the Patent Amendment process in India. However, we are observing very

disappointing developments as far as public interest safeguards in the same are

concerned.

As you are aware, Government of India has initiated a process of amending the

Patents Act to introduce product patent regime. The draft Bill for the amendment

is currently pending before the Group of Ministers (GoM). The GoM refused to

invite public comments on this issue. Provisions of the Bill go much beyond the

TRIPS (TRIPS+) requirements and compromise accessibility and availability of

drugs in the future. The main issues of concern in the Bill are :

a.. It proposes to extend the scope of patentability much beyond the TRIPS

requirements by amending Section 3(d) of the Patents Act to provide patents to

new use of even known medicines. There is no obligation under TRIPS to provide a

patent for either new use or new dosage of known medicines. The product patent

should be given only to new chemical entities and not to new use and dosage

forms. This will limit the number of patent protected drugs.

b.. The Bill proposes to do away with the pre-grant opposition procedure.

Pre-grant opposition is an important mechanism for civil society to oppose

frivolous patents. Currently there are approximately 6000 applications pending

in the mailbox protection. In the absence of pre-grant opposition, these 6000

applications would escape public scrutiny. Public scrutiny is crucial in light

of the fact that less than 500 drugs have been granted marketing approvals in

India between 1995-2004 indicating that the rest are trivial applications.

Hence, pre-grant opposition is absolutely essential for blocking trivial

patents.

c.. The Bill has not properly incorporated the August 30th Decision of the TRIPS

General Council, which permits the grant of compulsory licences for export

purpose to countries with no or insufficient manufacturing capacity in the

pharmaceutical sector. The Bill proposes to permit compulsory licensing to a

country with no or insufficient manufacturing capacity in the pharmaceutical

sector if there is a corresponding patent in the importing country. This ignores

the fact that in many instances, there may not be any patent protection in the

importing country because the deadline for Least Developing Countries (LDCs) to

comply with TRIPS is 2016. In this case, the Indian drug companies would not be

able to export to LDCs in the absence of a compulsory licence granted by the

LDC.

a.. Lastly, the compulsory licence regime within the present Patents Act

contains cumbersome procedures without any time line for the final disposal of

the application. This renders the compulsory licence system ineffective to curb

abuse of patents because procedural requirements take away the deterrent element

of the compulsory license mechanism.

The Government is planning to issue an ordinance to amend the Patent Act to

avoid debate. The Ordinance route of amendment will present a fait accompli and

simply postpone discussions on the Bill in Parliament and will scuttle the

democratic spirit of law making.

We therefore request you all to send an e-mail to the Prime Minister of India

seeking his intervention on the issue. Email ID: manmohan@... . If you

wish, you may use the following text.

Please pass on this message to others.

For AMTC

Anand Grover

E-mail: <aidslaw@...>

___________________________

Sample copy of protest letter.

Dear Mr. Prime Minister,

We are writing this letter to bring to your notice certain concerns regarding

the Patents Act amendment process and the content of the amendment. The Common

Minimum Programme of UPA government promised " to take all steps to ensure

availability of life savings drugs at reasonable prices " . However, the news

reports on amendment of Patents Act shows that the UPA government is moving to

an exactly opposite direction. We are afraid that the Patent (Amendment) Bill in

its present form seriously compromises accessibility and availability of

medicines, one of the primary components of Right to Health.

The draft Bill, not only fails to use the flexibility available within the TRIPS

Agreement (TRIPS) but also goes beyond TRIPS . In other words, the draft Bill

proposes patent protection more than what is required under TRIPS. We feel that

draft Bill provisions would give monopoly rights to pharmaceutical companies at

the cost of accessibility and availability of drugs under the product patent

regime. Hence, we seek your urgent intervention to safeguard accessibility and

availability of drugs. We urge you to make use of the flexibility available

under TRIPS to the optimum level.

Further, Group of Ministers' decision to not invite public comments make the

whole process secretive in nature and compromises transparency for such process.

There are also news reports about government's intention to bring an ordinance

for amending the Patent Act instead tabling a Bill. People and their

representatives have a right to be heard on the issues that affect their life.

Therefore, we demand that the Government should not choose the ordinance route

to amend Patents Act and the same to be introduced in the parliament for

deliberations.

We strongly demand,

1. No patents for known chemical molecules

2. Retain pre-grant opposition

3. No other TRIPS+ provisions

4. No Ordinance on Patent Amendment

Thanking you.